displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Contains lidocaine HCl 3%. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:
Each gram of Lidocaine HCl 3% Lotion contains ACTIVE: Lidocaine HCl 30 mg in a lotion base of INACTIVES: Aluminum sulfate, calcium acetate, cetyl alcohol, glycerine, mineral oil, methyl paraben, white petrolatum, glyceryl monostearate SE, propyl paraben, purified water, sodium hydroxide, sorbitan stearate, stearic acid and stearyl alcohol
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
For external use only. Not for ophthalmic use.
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
If irritation or sensitivity occurs or infection appears, discontinue treatment and institute appropriate therapy. Lidocaine HCl 3% Lotion should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or maybe the locus of abnormal sensation.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Apply a thin film to the affected area two or three times daily or as directed by a physician.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine HCl 3% Lotion is supplied in the following size:
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
|6oz. (177 mL) Bottle
PRINCIPAL DISPLAY PANEL – 177 mL Bottle Carton
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
HCl 3% LOTION
Net WT. 6 OZ (177 mL)